Inspections, Compliance, Enforcement, and Criminal Investigations
Crystal Care International Inc
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
|555 Winderley Pl., Ste. 200
Maitland, FL 32751
RETURN RECEIPT REQUESTED
May 22, 2009
Michael W. Nehr
President & CEO
Crystal Care International, Inc.
15941 North Florida Avenue
Lutz, FL 33549-5846
Dear Mr. Nehr:
During an inspection of your firm located in Lutz, Florida on December 9-10, 2008, investigators from the United States Food and Drug Administration (FDA) determined , that your firm manufactures the Crystal Ear Classic, Crystal Eaz, and Digital Crystal Ear. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or are intended to affect the structure or function of the body.
A review of your website reveals that you are promoting the Crystal Ear Classic, Crystal Eaz, and Digital Crystal Ear to compensate for impaired hearing. For example, your website lists the signs of hearing loss and indicates that if an individual suffers from any of,those signs, then the individual should call Crystal Care International's toll free number. Similarly, the Frequently Asked Questions section appears to indicate that Crystal Ear and Crystal Eaz are designed to help slight to moderate hearing losses and helps to minimize ringing in the ears. Accordingly, these products are hearing aids, as defined in 21 CFR § 874.3300, because they are "wearable sound-amplifying device[s]
that [are] intended to compensate for impaired hearing." This definition broadly encompasses both air conduction and bone conduction devices in a variety of styles (e.g., behind-the-ear, in-the-canal, body worn). Guidance for Industry and FDA Staff: Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products, February 25, 2009. Hearing aids must comply with additional regulatory requirements pertaining to patient and professional labeling under 21 CFR § 801.420 and conditions for sale under 21 CFR § 801.421.
The inspection revealed that these devices are adulterated within the meaning of section 501(h) of the Act, 21 U.S.C. 35 1(h), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the Current Good; Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation found at 21 CFR Part 820. These violations include, but are not limited to, the following:
1. Failure to establish procedures for quality audits, as required by 21 CFR 820.22. Specifically, your firm does not have any procedures for conducting quality audits.
2. Failure to establish and maintain procedures for acceptance of incoming product, as required by 21 CFR 820.80(b). Specifically, your firm does not have any procedures for acceptance or rejection of incoming product.
3. Failure to establish and maintain procedures for implementing corrective and preventive action, as required by 21 CFR 820.100. Specifically, your firm does not have any procedures for implementing corrective and preventive actions, including procedures addressing documentation. of corrective and preventative action activities.
4. Failure to establish and maintain procedures to control labeling activities, as required by 21 CFR 820.120. Specifically, your firm does not have any labeling procedures.
5. Failure to establish procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a). Specifically, your firm does not have any complaint handling procedures for receiving, reviewing, and evaluating complaints.
6. Failure to establish and maintain procedures to determine whether the complaint represents an event that is required to be reported to the FDA under 21 CFR Part 803, as per 21 CFR 820.198(a)(3). Specifically, your firm does not have any complaint handling procedures to ensure that all complaints are evaluated to determine whether the complaints should be filed as a Medical Device Report.
7. Failure to establish and maintain instructions and procedures for performing and verifying that the servicing meets specified requirements, as required by 21 CFR 820.200(a). Specifically, your firm does not have any procedures for servicing.
8. Failure to analyze service reports with appropriate statistical methodology, as required by 21 CFR 820.200(b). Specifically, your firm does, not have any procedures for analyzing service reports. In addition, the service reports were not analyzed following appropriate statistical methods.
9. Failure to establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements, as required by 21 CFR 820.50. Specifically, your firm does not have procedures to ensure that all purchased or otherwise received product and services conform to specified requirements.
10. Failure to maintain device master records (DMR), as required by 21 CFR 820.181 Specifically, the firm has not established a DMR.
Our inspection also revealed that your firm's devices are misbranded under section 502(t)(2) of the Act, 21 U.S.C.352(t)(2), in that your firm failed or refused to furnish material or information respecting the devices that is required by or under section 519 of the Act, 21 U.S.C. 360i, and 21 CFR Part 803 Medical Device Reporting (MDR) regulation. Specifically, your firm failed to establish, maintain and implement procedures for evaluating complaints to determine whether the complaint represents an event which is required to be reported to FDA, as required by 21 CFR Part 803.
Additionally, a review of our records revealed your establishment registration for the Crystal Ear®, Crystal Eaz®, and Digital Crystal Ear® is not current. There is no device listing for your devices. Consequently, your devices are misbranded under section 502(o) of the Act, 21 U.S.C. 352(0), in that the devices were manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510, 21 U.S.C. 360, was not included in a list required by section 510(j), 21 U.S.C. 360(j), and a notice or other information respecting the devices was not provided to the FDA as required by section 510(k), 21 U.S.C. 360(k).
We have received your response to the Form FDA 483 (FDA 483) regarding our investigator's observations noted on the FDA 483 issued at the closeout of the inspection. In your letter, dated December 16, 2008, you requested a time extension to respond to the FDA 483 observations by March 31, 2009. Although during the course of the current inspection you repeatedly refused to provide basic information concerning your firm's operations (including the name and address of your contract manufacturer, any distribution information, as well as any product labeling) to our investigator, we granted you the extension of time to respond by March 10,2009. We have received your response dated March 10, 2009. Your response indicates that Crystal Care International now has procedures for the violations noted in this letter, however, the procedures are inadequate. Furthermore, it is unclear whether any of the procedures have actually been implemented and are in compliance with the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation.
You should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action being initiated by the Food and Drug Administration without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties. Also, federal agencies are advised of the issuance of all Warning Letters about devices so that they may take this information into account when considering the award of contracts.
Please notify this office in writing within fifteen (15) working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violation(s), from occurring again. Include documentation of the corrective action you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.
FDA is requesting a regulatory meeting with your firm to discuss these violations. We would like to provide clarification on the regulatory requirements pertaining to your device and what you need to do to come into compliance with these requirements.
Your response should be sent to: Winston R. Alejo, Compliance Officer, 555 Winderley Place, Suite 200, Maitland, Florida, 32751. If you have any questions about the content of this letter please contact: Mr. Alejo at (407) 475-4731.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, Form FDA 483 (FDA 483), issued at the closeout of the inspection may be symptomatic of serious problems in your firm's manufacturing and quality assurance systems. You should investigate and determine the causes of these violations, and take prompt actions to correct the violations and to bring your products into compliance.
Emma R. Singleton
Director, Florida District